# K913804: Excelsior Single Lead Dispensing Set

- Pathway: 510(k) (Traditional)
- Applicant: Excel Medical, Inc.
- Decided: Feb 11, 1992 after 169 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jun 5, 2014 · Class II · Z-2070-2014: There is a potential for a leak. A molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids f

Source page: https://510kreport.com/device/K913804
Methodology: https://510kreport.com/methodology